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NCT Number: NCT06801691

The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe

In the EUthyroid2 intervention, measures are being developed and implemented in educational settings across the UK, Germany, Slovenia, the Republic of Cyprus, Bangladesh, and Pakistan to effectively raise awareness of the risks associated with iodine deficiency. Each participating country will employ three measurement points. The intervention will be tailored to the specific contextual characteristics of each implementation site. A process evaluation utilizing a convergent parallel mixed methods design will be conducted, involving surveys of students and teachers, as well as semi-structured interviews.

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Key information

Conditions

Iodine Deficiency

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh University of Health, Dhaka, Bangladesh

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About this study

Detailed Description:

BACKGROUND: Iodine deficiency (ID) is a leading risk factor for thyroid disorders and developmental impairments in offspring. It is recognized as one of the most preventable causes of mental impairment in children. The EUthyroid2 project aims to contribute to the prevention of ID and its associated symptoms and disease burden in adolescents across Europe and beyond.

AIM: This project seeks to develop and implement an educational intervention in various educational settings, effectively raising awareness of the risks associated with iodine deficiency.

METHODS: The intervention will be conducted in each participating country, with three clusters (secondary schools, high schools, and vocational schools) per country. The goal is to achieve a final sample of 4500 study participants in all countries combined, involving one baseline measurement and two follow-up assessments (2-4 weeks and 6-8 months post-intervention). Data will be collected at all measurement points, with variations in implementation accounted for due to differences between countries. To ensure the intervention's functionality and effectiveness, the project will consider recommendations for developing complex interventions, appropriate theoretical frameworks, and conduct a context analysis. Outcome measures will include a newly developed iodine awareness questionnaire (primary outcome) and an iodine-specific food frequency questionnaire. Additionally, socio-demographic characteristics will be measured. Descriptive analyses will be performed on all variables, with subgroup and country-specific analyses computed. A process evaluation will assess the implementation process using a convergent parallel mixed methods design, inviting teachers and students to participate in an online questionnaire. Semi-structured interviews will further enrich this evaluation.

CONCLUSION/OUTLOOK: The results of the EUthyroid2 project may assist health authorities across participating countries in implementing effective strategies to reduce iodine deficiency and its associated risks. Ultimately, this could lead to a sustainable decrease in the disease burden induced by iodine deficiency.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • sufficient language skills to understand the study information, informed consent

Exclusion criteria

  • none

Treatment and study plan

Experimental: Intervention group

Other

Educational materials: Iodine Feedback Tool, lecture on the topic of iodine and health, booklet, exercises, group assignments and a webpage This is a pre/post intervention with no control group.

Primary outcomes

  1. Change in awareness

    Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months) in students (13-17 years)

    • Change in awareness of iodine and iodine deficiency: Difference in iodine awareness is measured by an iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.

Secondary outcomes

  1. Changes between teaching modalities

    Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

    Differences in iodine awareness between students taught module A vs module A+B vs module A+C vs module A+B+C. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.

  2. Changes in vocational schools, high- and secondary schools

    Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

    Differences in iodine awareness between students in vocational schools vs high schools vs secondary schools. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.

  3. Change between age groups and gender distinctions

    Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

    Differences in iodine awareness between girls vs boys. Changes in iodine awareness are assessed by the iodine awareness questionnaire.

    Differences in iodine awareness between 13-year-olds vs 14-year-olds vs 15-year-olds vs 16-year-olds vs 17-year-olds. Changes in iodine awareness are assessed by the iodine awareness questionnaire. The scoring ranges from 1 to 22 points with higher scores indicating a better outcome of awareness.

    Gender and age will be self-reported in a socio-demographic questionnaire.

  4. Change in iodine intake

    Time frame: T1 (baseline) to T2 (2-4 weeks) and T3 (6-8 months)

    Dietary iodine intake is assessed through a food frequency questionnaire (FFQ), covering five main categories (cow's milk, fish, eggs, supplements, and salt) and regional components in each country. Each category is scored based on frequency (portions per day, week, or month), and individual sources are analyzed for iodine intake. For example, taking supplements 5-7 times a week or consuming a combination of multiple sources of cow's milk, fish and eggs a week may suggest sufficient intake. Regional differences are also considered, as salt is an iodine source in countries like Pakistan and Bangladesh, but not in the UK or Norway. The number of iodine sources will be compared before and after the intervention within each country, with a higher number of sources indicating a higher iodine intake). The number will differ according to the number of sources in each country.

Study contacts

Contact information is provided by the study sponsor or research team.

Henry Völzke

CONTACT

[email protected]

0049 3834 86 75 41

Sponsors and collaborators

Lead sponsor

EUthyroid

Other

Collaborators

  • EU Horizon
  • UK Research and Innovation

Registry information

Acronym: EUthyroid2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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